MSAT Equipment Qualification Lead (Sterile)

Lonza; Stein; On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance bonus

Benefits package

Job summary

Lonza in Stein, AG, Switzerland is seeking a senior MSAT leader to oversee the Equipment Qualification and Process Platforms function. You will manage people, resources and delivery, building MSAT expertise with coaching and succession planning.

This role drives qualification strategies across sterile drug product manufacturing throughout its lifecycle. You will establish governance for critical sterile technologies, including single-use systems, and ensure alignment with GMP and regulatory

Qualifications

• Must have sterile drug product manufacturing experience.
• Strong expertise in qualification, lifecycle management and aseptic technologies.
• Experience with audits, inspections and cross-functional partners.

Responsibilities

• Lead Equipment Qualification & Process Platforms with accountability for people, resources and delivery.
• Define strategic direction for Equipment Qualification and Process Platform activities aligning with site priorities.
• Ensure capability and governance for sterile manufacturing technologies including isolators and decontamination systems.
• Provide governance for Drug Product Process Platform ownership across thawing, compounding and filling technologies.
• Ensure Single-Use Systems capabilities and governance are established to support site needs.
• Establish MSAT governance framework aligned with GMP and regulatory expectations.

Skills

MSAT leadership

Equipment qualification

Process platform ownership

GMP & regulatory

Stakeholder management

English fluency

Education

MSc or PhD in Pharmaceutical Sciences/Engineering/Bioengineering

Job description

Lonza in Stein, AG, Switzerland is seeking a senior MSAT leader to oversee the Equipment Qualification and Process Platforms function. You will manage people, resources and delivery, building MSAT expertise with coaching and succession planning.

This role drives qualification strategies across sterile drug product manufacturing throughout its lifecycle. You will establish governance for critical sterile technologies, including single-use systems, and ensure alignment with GMP and regulatory